510(k) K981165

AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST by Germaine Laboratories, Inc. — Product Code JHI

K981165 is an FDA 510(k) premarket notification submitted by Germaine Laboratories, Inc. for the device "AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST". The FDA issued a decision of Substantially Equivalent on April 16, 1998. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Germaine Laboratories, Inc. has at least 7 other 510(k) clearances on record.